Epigenomics
Epigenomics (OTC:EPGNY) announced another delay to the US launch of its blood-based CRC diagnostic test Epi proColon and a moderate downgrade to its FY15 guidance. The FDA demands more evidence of increased compliance in CRC screening using Epi proColon, which is likely to necessitate a further study. With a current cash reach to H216, a cash call is likely before a possible US approval.
High compliance rate in test group likely causes delay
In its response to the ADMIT study concluded in May, the FDA has requested yet more data to show that Epigenomics’ blood-based test raises willingness to screen for CRC in the 75% of patients normally resisting a standard faecal-based FIT test. ADMIT showed 99.5% adherence to Epi proColon vs an exceptional 88.1% for FIT. Designed to assess if adherence to Epi proColon would be higher than FIT plus an 8.2% margin, the study fell short of statistical significance (p=0.059).
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